UMIN-CTR Clinical Trial

Public title

Six-month Kohzuki Exercise Program improves physical function in frail older people in multifunctional long-term care in a small group home: a randomized controlled pilot trial

Acronym

The effect of physical exercise for frail older people

Scientific Title

Six-month Kohzuki Exercise Program improves physical function in frail older people in multifunctional long-term care in a small group home: a randomized controlled pilot trial

Scientific Title:Acronym

The effect of physical exercise for frail older people

Region

Japan

Condition

The eligibility criteria for inclusion were (i) 65 years or older; (ii) frail (meeting the specified cut-off for three or more of the CHS frailty criteria: slow gait, weak grip, exhaustion, low energy expenditure, and weight loss) [4]; (iii) Mini-Mental State Examination [19] score >21; and (iv) absence of participation in aerobic exercise and strength training.

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

the aim of this study was to determine the effect of a 6-month structured KEP on physical function in frail older people in MSGH. The hypothesis was that the KEP would improve physical function in frail older people.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Short Physical Performance Battery(SPPB)

Key secondary outcomes

Barthel Index(BI)
Medical Outcomes Study 12-item Short Form Health Survey Instrument(SF-12)
Geriatric Depression Scale-Short Form 15(GDS)
Pittsburgh Sleep Quality Index(PSQI)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The Exercise Group participants engaged in the KEP 3 times a week for 6 months, totaling 72 sessions. All sessions began with 5 minutes of warm-up and stretching, followed by 30 minutes of lower-limb aerobic exercise using a Terasuerugo (Showadenki Co., Ltd., Osaka, Japan), and 5 minutes of cool-down and relaxation (72 sessions in all).

Interventions/Control_2

CG participants were asked to maintain their normal behavior over the same 6-month period.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

120

years-old

>

Gender

Male and Female

Key inclusion criteria

The eligibility criteria for inclusion were (i) 65 years or older; (ii) frail (meeting the specified cut-off for three or more of the CHS frailty criteria: slow gait, weak grip, exhaustion, low energy expenditure, and weight loss) [4]; (iii) Mini-Mental State Examination [19] score >21; and (iv) absence of participation in aerobic exercise and strength training.

Key exclusion criteria

The exclusion criteria for the participants were (i) any acute cardiorespiratory episode within 1 year before the study; (ii) neurological or neuromuscular disease that could interfere with the proper performance of assessment and/or exercise protocol; and (iii) dementia or psychiatric disorders.

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Kohzuki

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine & Rehabilitation Science

Zip code

Address

1-1, Seiryo street, Aoba ward, Sendai city

TEL

022-717-7351

Email

kohzuki@med.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Chaewon Lee

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine & Rehabilitation Science

Zip code

Address

1-1, Seiryo street, Aoba ward, Sendai city

TEL

022-717-7353

Homepage URL

Email

terramoris@dc.tohoku.ac.jp

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学大学院(宮城県)

Date of disclosure of the study information

2016

Year

09

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

07

Month

26

Day

Date of IRB

Anticipated trial start date

2016

Year

09

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

02

Day

Last modified on

2018

Year

09

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027492